In the UK, OA is the second most frequent reason for consultations with older patients in primary care.3
Most such consultations are with a doctor (the GP or family practitioner).133Primary care provides the arena
in which most patients with OA in the population who seek care from the UK NHS are seen and managed. In 2008, the UK NICE identified evidence-based interventions for patients with OA consulting in primary
care (Figure 6).15These included a core set of interventions considered potentially applicable to all patients
consulting about OA in primary care (represented by the inner circle in Figure 6).
Evidence has shown that most OA patients in primary care were not receiving or continuing with these
interventions24and that there was widespread dissatisfaction and pessimism among doctors, health
professionals and patients about primary care management of OA and about the potential to alter the
natural history of the minority who will progress to joint replacement surgery.22,41,42,44
This context provided the ambition and purpose for this second workstream of the NIHR programme RP-PG-0407-10386. The workstream comprised a suite of studies (MOSAICS) designed to develop practical evidence-based ways to support the implementation of NICE guideline core interventions in primary care and, thereby, to enhance the value of the primary care consultation for patients with OA.
The focus of the NICE core guidance is on self-management.15The guidance characterises self-management
in terms of access to information and advice, including specific advice about exercise and physical activity, optimal use of simple oral and topical analgesia and, when appropriate, weight loss. The OA research user group (RUG) at Keele (see Appendix 1) had highlighted, prior to submission of the NIHR programme proposal, that their main concern about NHS recommendations for self-management was, from the perspective of patients, the lack of information, support and help to adopt and maintain self-management approaches. This user view provided the underlying rationale for the content of the MOSAICS interventions. A model OA consultation for GPs in primary care backed up by new patient information, an electronic template for monitoring quality of care and referral for a series of practice nurse-led model OA consultations formed the ‘MOSAICS model of care’, and this was defined as the vehicle to deliver NICE guidelines into practice. The theoretical basis for developing the intervention to change GP behaviour is described in detail by Porcheret et al.134
Core self-care interventions
• Education, advice, information access
• Strengthening exercise, aerobic fitness training • Weight loss if overweight or obese
First-line analgesia • Paracetamol • Topical NSAIDs
The components of the MOSAICS approach were based on the Whole systems Implementing
Self-management Engagement (WISE) model,19which embraces the needs of the patient, the health-care
professional and the service. The key components in MOSAICS that were developed and evaluated in this workstream were as follows:
l Model OA consultations by GPs and practice nurses.
l Training for primary care health professionals to deliver model OA consultations.
l A new guidebook for patients, developed by patients and health-care professionals together, as the
principal source of written information.135
l An electronic computer-based method (the‘e-template’) for routine recording of components of quality
OA care by GPs and practice nurses.
l New nurse-led OA clinics in general practice.
The suite of individual studies developing and evaluating different components of the MOSAICS model were embedded in a framework provided by a cluster RCT. The trial investigated implementation of the new model of care at a practice level (process outcomes) in four primary care practices that adopted the different components of the model OA consultation compared with four practices that (with the exception of the e-template) did not, as well as the impact of this implementation on pain and disability in a subgroup of patients recruited into a
follow-up study (clinical outcomes). The trial was based on UK MRC complex trial principles.136
A second framework for studying aspects of adoption and implementation of the model OA consultation
was provided by normalisation process theory (NPT).137Adoption of new or complex interventions in primary
care is influenced by factors at three levels: the clinical encounter, the management and organisation of
the practice, and the wider health service context. Recognition of these influences is increasing,138but there
are few concrete examples that have investigated them. In studying the implementation of MOSAICS, we examined how GPs and practice nurses made sense of this complex intervention, what this meant for the way they worked and how this had to change, as well as which factors from the three levels were influencing
this‘sense-making’.139The framework supplied by these concepts from NPT was used in two ways. First, it
provided a structure for the research team in its approach to engaging with the practices by identifying factors facilitating implementation and overcoming barriers to delivering the MOSAICS intervention. Second, it provided a framework for analysing and evaluating the process of implementing the intervention.
Each component of the model OA consultation was studied separately, using a mixture of quantitative and qualitative techniques in order to establish its rationale, develop and evaluate its content and associated training, and test its acceptability with patients and professionals. The implementation of the components of the new model was investigated at a practice level in the trial through process measures of frequency of delivery and recording of care, and at an individual level through qualitative studies and surveys of patients and health-care professionals. The clinical effectiveness and cost-effectiveness of the programme was evaluated in the individual-level analysis of the subgroup that was followed up by self-report questionnaire in the cluster RCT.
Patient and public involvement (PPI) was present at every step of the process through a dedicated OA RUG (see Appendix 1).
The framework and component studies of MOSAICS
Each MOSAICS study or analysis is presented separately below, grouped into chapter sections: background (group 1), development and testing of interventions and quality-of-care measures including the e-template (groups 2 and 3), implementation of the new model of care (practice-level analysis), clinical effectiveness and cost-effectiveness (individual-level analysis) (group 4), patient and practitioner experience (group 5) and dissemination (group 6). Each study has aims, methods, results and published and practical outputs. The cluster RCT framework and populations are shown in Figure 7. The total practice population for the practice-level analysis is shown in blue and the subsample of the total practice population for the individual patient-level analysis is shown in green.
Practice-level analysis Eligible to be mailed survey questionnaire (n = 28,443) Responded to survey questionnaire (n = 15,083)
Consent to follow-up and medical record review if and
when they consult
(n = 11,290)
Reported joint pain in one of four OA sites
(n = 9110)
Population consulting with clinical OA Intervention 0–6 months n = 364 (7.74/100) Control 0–6 months n = 287 (6.51/100) n = 4408 n = 4702 Four intervention practices Four control practices Records tagged Subsample of practice-level cluster trial for
individual follow-up (n = 9110) Population consulting with clinical OA 0–6 months [n = 1118 (5.94/100)] Population consulting with clinical OA 0–6 months [n = 842 (5.65/100)] Total registered population ≥45 years (n = 18,835) Total registered population ≥45 years (n = 14,891) Four intervention practices Four control practices Total population consulting with a defined Read code for joint pain or
OA 0 to 6 months [n = 1960 (5.78/100)]
Registered population of eight general practices who are aged ≥ 45 years
(n = 33,726)
Total population consulting with a defined Read code for joint pain or OA
(‘clinical OA’) –18 to –12 months [n = 1761 (5.22/100)]
–12 to 6 months [n = 1827 (5.24/100)]
Total population consulting with a defined Read code for joint pain or OA
–6 to 0 months [n = 1851 (5.49/100)]
Template inserted in all eight practices
Cluster randomisation
Individual patient-level analysis
The study populations
The registered populations of the eight participating general practices who were aged≥ 45 years
(n= 33,726) provided the population base for the MOSAICS studies. The eligibility for the participation of
these practices, their staff and their patients is listed in Appendix 2 (see MOSAICS eligibility criteria). There were three populations selected from this base in the pre-randomisation phase.
l Population survey responders. All persons aged≥ 45 years registered with one of eight participating
practices were sent a general health questionnaire to establish baseline pre-randomisation patterns of
joint pain and OA in the population. A series of baseline analyses of all‘survey responders’ were
performed to determine the background frequency of multisite pain, self-reported uptake of NICE recommended treatments and prevalence of physical activity among persons with joint pain in this population (MOSAICS study 1.1, see Study 1.1: self-reported prevalence and patterns of osteoarthritis and its treatment in the registered population of primary care).
l Total OA consulting population. All consulters aged≥ 45 years who were coded on the practice
medical records system as having consulted about joint pain or OA, regardless of whether or not they
had responded to the baseline population survey, formed the‘total OA consulter population’ (Figure 7
and Box 2). This anonymised population provided occurrence estimates of joint pain and OA in the
participating practices, using the total registered population aged≥ 45 years of the participating
practices as the denominator (n= 33,726) (see Figure 7).
l Consenter population. Those who responded to the survey, who consented to follow-up and a recorded
review, and who had reported pain in at least one OA joint site (hand, hip, knee or foot) at baseline were eligible for individual follow-up in the cluster trial. This population was a subgroup of the second population above, drawn from the baseline survey responders in the first population. A consent form to further contact and to use of individual medical records was included in the survey. Survey responders
with pain in at least one joint who gave their consent formed the‘consenter population’. This identified,
pre-randomisation, the pool of patients in all practices who would be willing to be recruited and followed up individually in the main cluster trial if they consulted their GP with joint pain during the randomisation phase. Such pre-randomisation of a consenting population of potential future eligible trial
participants guards against bias in recruiting individuals within a cluster design post randomisation.109
This subgroup, the self-reported questionnaires they completed during the follow-up phase and details
from their medical records created the basis for the‘individual-level’ analysis in the cluster RCT of clinical
effectiveness and cost-effectiveness of the implementation of the new model of care (MOSAICS studies
4.2–4.3, see Study 4.2: effect of the MOSAICS programme on patient-reported outcomes and Study 4.3:
cost-effectiveness of the MOSAICS intervention: health economic evaluation). The subgroup also
provided the sampling framework for additional‘individual-level’ quantitative and qualitative studies of
implementation (MOSAICS studies 5.1–5.4, see Study 5.1: implementing a complex intervention in
practice– an evaluation using a theoretical framework, Study 5.2: experiences of model consultations –
patients, Study 5.3: experiences of model consultations– general practitioners, and Study 5.4:
experiences of the model consultation– nurses).
BOX 2 ‘Read coding’ of OA-related consultations
All UK GPs, including those in the participating practices, record on their practice computer software the reason why a patient consults them, using an established morbidity coding system called‘Read codes’. These codes can be symptoms or diagnoses. Preliminary work in MOSAICS by academic GP members of the team identified a complete list of symptom and diagnostic codes (summarised throughout this report as‘joint pain and OA codes’) which were agreed as representing all possible presentations of clinical OA. The list of Read codes appears in www.keele.ac.uk/mrr,140Jordan et al.141and Edwards et al.132
A practice-level intervention (the quality-of-care e-template, which prompted OA assessment and NICE core OA interventions by the GP) was developed and introduced into all eight practices. This template was a pop-up computer screen that appeared whenever joint pain and OA consulting codes were entered. The effect of this intervention on routinely recorded items of care (such as prescriptions for OA) was investigated by a before-and-after comparison of downloaded anonymised practice record data 12 months before and 6 months after installation of the template in all eight practices [MOSAICS study 3.1, see Study 3.1: the
osteoarthritis quality-of-care template (the‘e-template’)]. In the subsequent cluster RCT of the MOSAICS
intervention, this population (all patients consulting with OA symptoms or diagnosis in the participating practices) and the anonymised measures of quality of care provided by the template generated the level
and method, respectively, of outcome analysis for the‘practice-level’ implementation study. This compared
anonymised downloaded consultation data between intervention and control populations (MOSAICS
study 4.1, see Study 4.1: implementation of the MOSAICS intervention– practice-level effect on quality of
care for patients with osteoarthritis).
Development studies
The development and testing of components of the model OA consultations and of the e-template were
conducted in the pre-randomisation phase [MOSAICS studies 1.2, 2.1–2.5, 3.1 and 3.2, see Study 1.2:
establishing the current evidence base for multidisciplinary osteoarthritis interventions in primary care settings;
Study 2.1: development of the content of a‘model’ general practitioner consultation and the training
intervention to deliver it; Study 2.2: evaluation of intervention workshops; Study 2.3: development of the content of a model osteoarthritis consultation with a practice nurse and the training package for nurses to deliver it; Study 2.4: evaluation of practice nurse training to support osteoarthritis self-management; Study 2.5: development of the opportunistic osteoarthritis consultation with health-care professionals; Study 3.1:
the osteoarthritis quality-of-care template (the‘e-template’); and Study 3.2: developing patient-reported
outcomes with the osteoarthritis research user group).
The main trial process
The eight practices were randomly allocated to intervention practices and control practices to form the cluster trial design. All practices continued to use the e-template to record care. Following training of GPs and practice nurses, consulters with joint pain or OA in the intervention practices received the MOSAICS model of care, whereas consulters with joint pain or OA in the control practices received usual care.
Practice-level outcomes
Practice-level outcomes in the cluster trial provided process measures of implementation of the model consultation in the intervention practices compared with controls and included:
l the proportion of consulters with joint pain or OA, whose e-template was completed in the
post-randomisation period and who met the quality criterion for each item of care on the template
l the proportion who were referred to the nurse OA clinic
l changes in routine measures of OA care, such as prescribed medication and referrals to physiotherapy
and radiography departments.
Individual-level outcomes
In the subgroup of individuals recruited within the cluster trial who were followed up post consultation at 0, 3, 6 and 12 months with self-report questionnaires, the extent of implementation of the MOSAICS model of care was further explored (e.g. in questions recalling the content of the consultations they had experienced, together with items on satisfaction with care). The main clinical outcomes of pain and disability were measured in this subgroup. Health economic analysis used both self-report questionnaires and data drawn from the medical records of this subgroup.
Qualitative interviews
Qualitative interviews were conducted with samples of patients after consultation and with health-care professionals delivering the new model of care (GPs and practice nurses) to explore experience and perspectives on the interventions.
Patient and public involvement in the MOSAICS studies
The OA RUG at Keele University had provided the initial impetus and thread for the whole programme (see Appendix 1) by highlighting that a desire expressed by patients to try self-management approaches was not matched by sufficient active and informed professional NHS support to do so.
The RUG continued to play a substantial part in the creation, shaping, delivering and evaluation of many important components of the MOSAICS suite of studies. An overview of RUG activity in MOSAICS is as follows.
Development and design of a guidebook for use in the osteoarthritis consultations
This was a stand-alone piece of work that pre-dated the NIHR programme RP-PG-0407-10386 and was
published collaboratively by researchers and patients.135,142It was introduced and evaluated in the
programme as a component of the model GP and nurse OA consultations. The OA guidebook differs from conventional patient education materials in that it contains lay, as well as biomedical, evidenced-based knowledge.
Five members of the OA RUG helped to shape the content of the guidebook. They reviewed a summary of
qualitative research of people’s experiences of living with OA to identify information needs, drawing on
their own lived experience to suggest what information was required to meet the information needs of newly diagnosed patients. They also reviewed all draft materials.
Advice on content of the baseline population questionnaire
The aim of patients’ involvement here was to critically assess a postal questionnaire that was used both as
the basis for the background survey and as a means to recruit potential participants for the later follow-up stage of the cluster RCT. As a result of their feedback, changes to the questionnaire were made.
Involvement in the Delphi consensus study to inform the content of a model general practitioner consultation with osteoarthritis patients
The aim was to ask patients what they think should happen or should be done when older people with joint pain consult a GP for the first time. A 1-hour meeting was held to explain the consensus exercise and to discuss aspects of consultations. OA RUG members then completed two postal questionnaires that listed all the possible things that could happen during the consultation and decided which they thought should be included. For the first round, they were asked to consider this if time was no object. In the second round, they were asked what should be included in an initial 10-minute consultation. OA RUG members then returned for a follow-up meeting to discuss items on the questionnaires and to give feedback on the
consensus method used to create the final content for the model consultations.143,144
Development of quality indicators for general practice consultations
A quality indicator describes the performance of something. It could be an action or task (e.g. GP recording information) or a heath outcome (e.g. lower blood pressure or reduced pain). Quality indicators are used to measure standards of care and whether or not they are consistent with what is thought to be best care. A list of quality indicators for the content of general practice consultations for the MOSAICS studies was defined
by a systematic review.145This list was taken to the OA RUG and translated by the OA RUG into questions
that could go into a questionnaire as part of the main study to ask patients about their experiences of the
new consultation being tested. Therefore, some of the questions in this‘patient consultation questionnaire’
This work by the OA RUG was also used as the basis to explore international comparisons of PPI methods. In collaboration with Norwegian, Danish and Portuguese colleagues, results of patient involvement across these three countries were compared. The format developed by the OA RUG was found to be almost
identical to a format being tested for OA quality indicators in Norway, which also included patient partners.146
Analysis of data from the qualitative studies
Four members of the RUG assisted one of the qualitative research teams with the analysis of audio- recordings of nurse-led OA clinics. The RUG members were provided with transcripts of the clinics and asked to identify themes and to comment on the interactions between the nurse and the patients. The